Inspection Record

Central Admixture Pharmacy Services Inc — FDA 483 Findings

US FDAInspected 2025-09-05Published 2025-12-01 7 findingsDeviation, CAPA, and investigationMaterial and supplier controlLaboratory and QC controlsAseptic processing and sterility assuranceQuality unit oversight

Inspectors Homero W AguilarThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Deviation, CAPA, and investigation

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

2Material and supplier control

Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.

3Laboratory and QC controls

Established standards, sampling plans and test procedures are not followed.

4Deviation, CAPA, and investigation

Written records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.

5Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

6Material and supplier control

Establishment of the reliability ofvthe component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.

7Quality unit oversight

The responsibilities and procedures applicable to the quality control unit are not fully followed.

About this record

Extracted automatically from the document US FDA published on 2025-12-01. The source is available at the link above.

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

Translation and classification are automated and may differ in nuance from the source.

Other records for this company

2025-09-05 · US FDA · 4 findings2015-07-11 · US FDA · 6 findings2024-08-13 · US FDA · 29 findings2024-05-21 · US FDA · 17 findings2024-05-14 · US FDA · 4 findings2023-08-25 · US FDA · 14 findings
Central Admixture Pharmacy Services Inc findings history — including this company's other documents US FDA documents, 2025 Go to Findings search